Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-8560a
Trade NameDose FormStrengthIdentifier
Arrow - Amlo 10Tablet10 mg
SponsorApplication dateRegistration situationClassification
Actavis New Zealand Limited
P O Box 128 244
Remuera
Auckland 1541
26/4/2010Not available
Approval date: 23/9/2010
Notification date: 21/11/2013
Prescription
Reference product: Norvasc Tablet 10 mg

Composition

ComponentIngredientManufacturer
tabletActive 
 Amlodipine besilate 13.88 mg (equivalent to 10 mg Amlodipine)Dr Reddy's Laboratories Limited
Unit III, Plot No 116, IDA Bollaram
Jinnaram Mandal
Medak District
Telangana 502 325
India
  Glochem Industries Limited
Survey Nos. 36, 37 & 46, Plot No. 77
Jawaharlal Nehru Pharmacity
Thanam Village, Parawada Mandal, Visakapatnam
Andhra Pradesh 502 325
India
 Excipient 
 Calcium hydrogen phosphate dihydrate
 Colloidal silicon dioxide
 Magnesium stearate
 Microcrystalline cellulose
 Sodium starch glycolate

Production

Manufacturing stepManufacturer
Finished Product TestingIpca Laboratories Limited
Plot No 255/1
Athal
Silvassa
Dadra and Nagar Haveli (U T) 396 230
India
Manufacture of Final Dose FormIpca Laboratories Limited
Plot No 255/1
Athal
Silvassa
Dadra and Nagar Haveli (U T) 396 230
India
PackingIpca Laboratories Limited
Plot No 255/1
Athal
Silvassa
Dadra and Nagar Haveli (U T) 396 230
India
NZ Site of Product ReleaseActavis New Zealand Limited
33A Normanby Road
Mount Eden
AUCKLAND

Packaging

PackageContentsShelf Life
Blister pack, PVC/PVDC28 tablets24 months from date of manufacture stored at or below 25°C
Blister pack, PVC/PVDC56 tablets24 months from date of manufacture stored at or below 25°C
Blister pack, PVC/PVDC84 tablets24 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE100 tablets24 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE250 tablets24 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE500 tablets24 months from date of manufacture stored at or below 25°C

Indications

Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.

Amlodipine is indicated for the first line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
20/10/2014Self-Assessable Change NotificationFinished product specifications/test methods - Grade 1 (Self assessable)Notified23/10/2014 
26/4/2010New Intermediate-risk Medicine ApplicationAdditional name - Grade 1Granted 23/9/201011/5/2010 
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